People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
NCT07207148 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-03-17
Summary
The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not.
For Aim 1, the cohort, patient-derived disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest.
For Aim 2, the clinical trial, PIRA will be measured pre-GLP-1 start and at study end (week 72). A composite score of disability, similar to the ORATORIO13 trial will be constructed including EDSS score, 25-foot timed walk, 9-hole peg test, and SDMT score.
Conditions
Interventions
- DRUG
-
GLP-1
Glucagon-like peptide-1 agonist agent is the study agent of interest. This study will not supply the GLP-1 drug but depends on the patient's clinical prescription of this drug.
- DRUG
-
Ocrelizumab (US)
All participants will be treated with Ocrelizumab for the indication of MS; however, the study will not provide Ocrelizumab as it will be part of the participant's routine clinical care.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Farrah J Mateen · Northwestern University
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-15
- Primary Completion
- 2028-04-01
- Completion
- 2028-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)
NCT07282574 ·Status: RECRUITING ·Phase: PHASE2
-
Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis
NCT03025269 ·Status: COMPLETED
-
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
NCT01194570 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting
NCT03589105 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis
NCT06104683 ·Status: WITHDRAWN ·Phase: PHASE2
-
Endpoint Calibration for a Phase 2 Study of Lisinopril in Multiple Sclerosis
NCT02369926 ·Status: UNKNOWN ·Phase: PHASE2
-
A Systems Approach to Understanding Disease Processes in Multiple Sclerosis
NCT05081700 ·Status: COMPLETED
-
A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis
NCT03523858 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis
NCT06677710 ·Status: SUSPENDED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
NCT04035005 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
NCT02861014 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714
NCT03691077 ·Status: UNKNOWN ·Phase: PHASE3
-
Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS
NCT05974852 ·Status: COMPLETED
-
Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)
NCT05974839 ·Status: COMPLETED
-
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
NCT07067463 ·Status: RECRUITING ·Phase: PHASE3
-
Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
NCT04855617 ·Status: COMPLETED
-
A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis
NCT03972306 ·Status: COMPLETED ·Phase: PHASE1
-
A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT01808482 ·Status: TERMINATED ·Phase: PHASE1
-
Ocrelizumab Access by Socio-Economic Status
NCT05131984 ·Status: COMPLETED
-
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
NCT06735248 ·Status: RECRUITING ·Phase: PHASE2
-
Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
NCT02141022 ·Status: COMPLETED ·Phase: NA
-
A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
NCT02977533 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Highresolution Electroencephalography (EEG)
NCT01765361 ·Status: COMPLETED
-
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
NCT06675955 ·Status: RECRUITING ·Phase: PHASE3
-
Effects of Ocrevus in Relapsing Multiple Sclerosis
NCT04387734 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4